Randomized Phase II-III Trial of Post-operative Treatment of Pancreatic Adenocarcinoma: Gemcitabine Versus PEFG Followed by Radiochemotherapy With Concomitant Continuous Infusion of 5-fluorouracil
- Assess the 1-year progression-free survival of patients with stage IB, II, or III
adenocarcinoma of the pancreas treated with adjuvant therapy comprising gemcitabine
with vs without cisplatin, epirubicin hydrochloride, and fluorouracil followed by
chemoradiotherapy with fluorouracil or capecitabine. (Phase II)
- Compare the 2-year overall survival of patients treated with these regimens. (Phase
- Assess the feasibility and toxicity of these regimens in these patients.
- Assess the impact of these regimens on the quality of life of these patients.
- Assess the pattern of relapse in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center and radical surgery. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 1 hour on days 1, 8, and 15.
Treatment repeats every 28 days for 3 courses in the absence of disease progression or
- Arm II: Patients receive cisplatin IV over 1 hour and epirubicin hydrochloride IV on
day 1 and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Patients also
receive fluorouracil IV continuously beginning on day 1 or oral capecitabine. Treatment
repeats every 28 days for 3 courses in the absence of disease progression or
Beginning 2-4 weeks after the completion of chemotherapy, patients in both arms undergo
radiotherapy 5 days a week for 6 weeks. Patients also receive concurrent fluorouracil IV
continuously or oral capecitabine during radiotherapy.
After completion of study treatment, patients are followed up every 3 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
1-year progression-free survival (Phase II)
every 3 months during the first 2 years, every 6 months afterwards
Michele Reni, MD
Istituto Scientifico H. San Raffaele
Italy: Ministry of Health